TEMPO 451415V0Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705032007870), received between Jun 15, 2019 and Nov 13, 2023 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A PATIENT WAS UNDERGOING AN ENDOVASCULAR PROCEDURE FOR RIGHT LEG STENOSIS. DURING TREATMENT, THE RADIOPAQUE TIP OF THE 4F TEMPO BERENSTEIN II (BERN 2) DIAGNOSTIC CATHETER BROKE OFF INSIDE THE PATIENT'S ARTERY. THE SURGEON REALIZED THIS IMMEDIATELY. SMALL VASCULAR BALLOONS WERE INSERTED AND INFLATED DISTAL TO THE FOREIGN BODY, AND 'DRAGGED' THE TIP INTO THE SHEATH. THE PATIENT WAS GIVEN HEPARIN REVERSAL. ALL DEVICES (INCLUDING THE FOREIGN BODY) WERE THEN REMOVED FROM THE PATIENT AND PRESSURE HELD TO ARTERY FOR TWENTY (20) MINUTES. NO FURTHER TREATMENT COULD BE GIVEN TO THE PATIENT AT THIS TIME DUE TO THE INCIDENT. PATIENT WILL REQUIRE A RETURN TO THEATRE FOR ORIGINAL TREATMENT. DEVICE PICTURES WERE RECEIVED FOR REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18124539 ↗
• InjuryOct 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE WHITE TIP (RADIOPAQUE TIP) DETACHED FROM THE 4F BER II TEMPO 0.38¿ 65 CM ANGIOGRAPHIC CATHETER AND IT WAS EMBEDDED IN THE PATIENT'S ARTERY WALL PLAQUE AND SEEN ON X-RAY. THE SEGMENT WAS NOT RETRIEVED; IT WAS EMBEDDED IN THE PATIENT'S PLAQUE. THE ARTERY WAS STENTED BY THE PHYSICIAN. THE PATIENT IS IN STABLE CONDITION. TWO (2) IMAGES WERE RECEIVED FOR REVIEW. THERE WERE NO ANOMALIES NOTED WHEN THE PRODUCT WAS REMOVED FROM THE PACKAGE. THE PRODUCT WAS STORED, HANDLED, INSPECTED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. ADDITIONAL EVENT DETAILS WERE REQUESTED; HOWEVER, NOT PROVIDED. THE DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18023258 ↗
• MalfunctionAug 21, 2023Crack; Crack

  AS REPORTED, THE DISTAL TIP OF A 4F 65CM BERENSTEIN (BERN) 2 TEMPO DIAGNOSTIC CATHETER BROKE DURING THE REMOVAL OF THE DEVICE FROM THE PATIENT AND WAS CLOSE TO SEPARATING. THE DEVICE WAS ABLE TO BE REMOVED EASILY FROM THE PATIENT AND REMAINED IN ONE PIECE DURING ITS REMOVAL. THERE WAS NO REPORTED INJURY TO THE PATIENT AND NO TRAUMA WAS CAUSED TO THE PATIENT'S ARTERY. THIS WAS DURING A PROCEDURE TO TREAT A POPLITEAL ARTERY LESION. THE DEVICE WAS NEVER PLACED IN AN ACUTE BEND DURING THE PROCEDURE, AND THERE WAS NO EVIDENCE THAT THE CATHETER WAS STUCK INSIDE OF THE PATIENT AT ANY POINT. THE DEVICE WILL BE RETURNED FOR EVALUATION. THE HOSPITAL REPORTED THIS EVENT DIRECTLY TO THE ANSM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17584270 ↗
• MalfunctionDec 16, 2021Crack; Crack

  AS REPORTED, THE PHYSICIAN NOTICED THE CATHETER HUB-END OF THE CATH TEMPO 4F BER II 65CM WAS FRACTURED DURING INITIAL USAGE AFTER OPENING THE PACKAGING. THE FRACTURED CATHETER HUB HAD REDUCED THE ¿TORQUE ABILITY¿ OF THE CATHETER DURING USAGE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13021542 ↗
• MalfunctionJun 15, 2021Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, A 4F 65CM BERENSTEIN II (BER II) CATH TEMPO DIAGNOSTIC CATHETER WAS OPENED, AND THE DOCTOR NOTICED THAT THE CATHETER HAD A HOLE IN THE SIDE. THE PROCEDURE WAS COMPLETED WITH ANOTHER TEMPO CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11999935 ↗
• MalfunctionJul 2, 2019Material Frayed; Material Frayed

  DURING USE, THE TEMPO DIAGNOSTIC CATHETER TIP IS DAMAGED OPEN AND WASN'T USED. ADDITIONAL INFORMATION WAS RECEIVED AND A FRAYED/SPLIT/TORN CONDITION WAS OBSERVED AT THE DISTAL TIP. THERE WAS NO PATIENT INJURY. THE CATHETER WAS NOT USED IN THE PATIENT, THE STAFF WAS PREPARING THE EQUIPMENT AND NOTICED THE DAMAGED CATHETER. THE DEVICE IS AVAILABLE FOR ANALYSIS. NO OTHER INFORMATION COULD BE OBTAINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8755611 ↗
• InjuryJun 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, TWO TEMPO CATHETERS (CATH TEMPO 4F BER II 65CM, CATH TEMPO 4F MP A1 (I) 65CM, CATH TEMPO 4F BER II 65CM) BECAME SEPARATED WHILE BEING USED WITH A NON-CORDIS LIVER AND BIOPSY SET. THE SEPARATED SEGMENTS MIGRATED TO THE LUNG ARTERIES AND WERE SNARED/RETRIEVED USING AN UNKNOWN DEVICE. THE DEVICES WERE CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS. THREE DIFFERENT CORDIS PACKAGES WERE RETURNED WITH ONLY TWO CORDIS CATHETERS. IT IS UNKNOWN WHICH LOT CORRESPONDS WITH WHICH CATHETER. THE DEVICE DID NOT KINK IN THE AREA OF SEPARATION. THE DEVICE SEPARATED APPROXIMATELY 2.5CM AND 2.3CM FROM THE DISTAL END.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8702380 ↗